Merck Wins Positive EU CHMP Opinion for KEYTRUDA Plus Padcev in Resectable Muscle-Invasive Bladder Cancer

RegulationProduct / Tech Impact 4
โดย Business Wire·EU·Read original
Summary · why it matters

Merck announced that the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of KEYTRUDA, the company's anti-PD-1 therapy, in combination with Padcev as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment for adults with resectable muscle-invasive bladder cancer. The recommendation, which also includes KEYTRUDA SC, known as KEYTRUDA QLEX in the U.S., will now be reviewed by the European Commission for marketing authorization in the European Union, Iceland, Liechtenstein and Norway, with a final decision expected by the fourth quarter of 2026. The opinion is based on results from the Phase 3 KEYNOTE-B15 trial, also known as EV-304, conducted in collaboration with Pfizer and Astellas, in which the perioperative regimen reduced the risk of event-free survival events by 47% (HR=0.53) and the risk of death by 35% (HR=0.65) versus neoadjuvant chemotherapy and surgery in cisplatin-eligible patients, while pathologic complete response reached 55.8% versus 32.5%. If approved, KEYTRUDA plus Padcev would become the first and only PD-1 inhibitor plus antibody-drug conjugate regimen in the European Union for patients with MIBC regardless of cisplatin eligibility. In June 2026, the European Commission approved the combination for cisplatin-ineligible adults with resectable MIBC based on the Phase 3 KEYNOTE-905 trial, and in July 2026 the U.S. Food and Drug Administration approved it for adults with MIBC regardless of cisplatin eligibility based on KEYNOTE-B15.

Impact on stocks 4

Biotech & Genomic Medicine▲ · 3 stocks
Merck & Company Inc
MRK
▲ PositiveRegulationrelevance

EU CHMP positive opinion recommends approval of KEYTRUDA plus Padcev for resectable muscle-invasive bladder cancer, advancing toward EU marketing authorization.

Astellas Pharma Inc.
4503
▲ PositiveRegulationrelevance

The positive CHMP opinion is based on the Phase 3 KEYNOTE-B15/EV-304 trial conducted in collaboration with Astellas, whose Padcev is part of the recommended regimen.

Pfizer Inc
PFE
▲ PositiveRegulationrelevance

The positive CHMP opinion is based on the Phase 3 KEYNOTE-B15/EV-304 trial conducted in collaboration with Pfizer, whose Padcev is part of the recommended regimen.

Critical Materials & Supply Chain▲ · 1 stocks

Theme Impact 3

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